Study of Zoledronic Acid Versus Observation on Bone Mineral Density and Incidence of Micrometastasis in Women Undergoing Pelvic Radiation for Cervical Cancer
| Status: | Terminated |
|---|---|
| Conditions: | Cervical Cancer, Women's Studies |
| Therapuetic Areas: | Oncology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | August 2009 |
| End Date: | March 2010 |
Randomized Phase II Study of Zoledronic Acid vs Observation on Bone Mineral Density and Incidence of Micrometastasis in Women Undergoing Pelvic Radiation for Cervical Cancer
The treatment of cervical cancer with chemotherapy and radiation will make women post
menopausal (no estrogen from the ovaries), if a woman is not already in menopause. Estrogen
plays a key role in maintaining bone health. Therefore, these women are at higher risk of
getting osteoporosis (decrease minerals in the bone) and bone fractures. The overall purpose
of this research is to look at the effects of zoledronic acid (Zometa) on preventing bone
loss. Studies have also shown that zoledronic acid may prevent metastasis to the bone which
can occur in women with cervical cancer. Zometa is investigational (not approved by the Food
and Drug Administration (FDA)) in this study to prevent metastasis to the bone in women with
cervical cancer. Therefore, the goal of this study is to also look at the effects of
zoledronic acid (Zometa) on circulating tumor cells in the bone marrow and blood. This study
is being done to find a way to prevent bone loss and metastasis to the bone in women
undergoing chemotherapy and radiation for cervical cancer. An additional component of the
study is to assess the importance of stress on immune markers in blood during standard
treatment.
menopausal (no estrogen from the ovaries), if a woman is not already in menopause. Estrogen
plays a key role in maintaining bone health. Therefore, these women are at higher risk of
getting osteoporosis (decrease minerals in the bone) and bone fractures. The overall purpose
of this research is to look at the effects of zoledronic acid (Zometa) on preventing bone
loss. Studies have also shown that zoledronic acid may prevent metastasis to the bone which
can occur in women with cervical cancer. Zometa is investigational (not approved by the Food
and Drug Administration (FDA)) in this study to prevent metastasis to the bone in women with
cervical cancer. Therefore, the goal of this study is to also look at the effects of
zoledronic acid (Zometa) on circulating tumor cells in the bone marrow and blood. This study
is being done to find a way to prevent bone loss and metastasis to the bone in women
undergoing chemotherapy and radiation for cervical cancer. An additional component of the
study is to assess the importance of stress on immune markers in blood during standard
treatment.
OBJECTIVES
- To determine the incidence of disseminated tumor cells (DTCs) in bone marrow and
circulating tumor cells (CTCs) in the blood of women with cervical cancer at diagnosis
and 3 to 9 months after chemotherapy and pelvic radiation with and without Zometa.
- To determine the change in biochemical markers of bone turnover from diagnosis to 9
months after radiation in women receiving chemoradiation for cervical cancer with and
without Zometa.
- To determine change in bone mineral density from diagnosis to 9 month after
chemoradiation with and without Zometa.
- To determine if depressed and anxious mood are associated with greater impairment of
adaptive immunity (ratio of Th1/Th2) and higher levels of angiogenesis (VEGF) in
peripheral blood of cervical cancer patients.
- To examine the relationship of standardized uptake values (SUV)Max and metabolic
heterogeneity in the primary tumor and evidence of persistent/recurrent disease on the
3 and 9 month Fludeoxyglucose (FDG)-Positron Emission Tomography (PET) scans with DTCs
and CTCs.
- To determine the incidence of disseminated tumor cells (DTCs) in bone marrow and
circulating tumor cells (CTCs) in the blood of women with cervical cancer at diagnosis
and 3 to 9 months after chemotherapy and pelvic radiation with and without Zometa.
- To determine the change in biochemical markers of bone turnover from diagnosis to 9
months after radiation in women receiving chemoradiation for cervical cancer with and
without Zometa.
- To determine change in bone mineral density from diagnosis to 9 month after
chemoradiation with and without Zometa.
- To determine if depressed and anxious mood are associated with greater impairment of
adaptive immunity (ratio of Th1/Th2) and higher levels of angiogenesis (VEGF) in
peripheral blood of cervical cancer patients.
- To examine the relationship of standardized uptake values (SUV)Max and metabolic
heterogeneity in the primary tumor and evidence of persistent/recurrent disease on the
3 and 9 month Fludeoxyglucose (FDG)-Positron Emission Tomography (PET) scans with DTCs
and CTCs.
Inclusion Criteria:
- Histologically proven squamous, adenosquamous or adenocarcinoma International
Federation of Gynecology and Obstetrics (FIGO) Stage IB-IVA of the uterine cervix
undergoing initial radiation and cisplatin based chemotherapy for primary treatment.
- Gynecologic Oncology Group performance status of 0, 1, or 2.
- Patients with ureteral obstruction must undergo stent placement or nephrostomy tube
placement prior to study entry.
- Age >= 18 years.
- Patients must have signed informed consent.
- Patients must have adequate:
- Bone marrow function: absolute neutrophil count (ANC) greater than or equal to
1,500/ul, equivalent to Common Toxicity Criteria (CTCAE) grade 1. Platelets
greater than or equal to 100,000/ul.
- Renal function: creatinine less than or equal to 1.5 x institutional upper limit
normal (ULN). If creatinine is greater than 1.5 x ULN, creatinine clearance must
be greater than 60 ml/min.
- Hepatic function: bilirubin less than or equal to 1.5 x ULN. AST and alkaline
phosphatase less than or equal to 2.5 x ULN.
- Neurologic function: neuropathy (sensory and motor) less than or equal to CTCAE
grade 1.
- Coagulation: prothrombin time (PT) such that the international normalized ratio
(INR) is < 1.5 (INR may be between 2 and 3 if a patient is on stable dose of
therapeutic warfarin) and a PTT < 1.2 times control.
Exclusion Criteria:
- Evidence of sepsis or severe infection.
- Previous or current treatment for osteoporosis. Patients with denovo osteoporosis are
also excluded.
- Evidence of bone metastasis.
- Current active dental problems including infection of the teeth or jawbone (maxilla
or mandibular); dental or fixture trauma or a current or prior diagnosis of
osteonecrosis of the jaw (ONJ), or exposed bone in the mouth, or of slow healing
after dental procedures.
- Recent (within 6 weeks) or planned dental or jaw surgery (e.g., extraction,
implants).
- Patients with history of other invasive malignancy (treatment within the last 5
years) other than non-melanoma skin cancer.
- Patients with known hypersensitivity to Zometa or other bisphosphonates.
- Patients who are pregnant or breast feeding.
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